Cleared Abbreviated

ACE CALIBRATOR

K141728 · SENTINEL CH. SpA · Chemistry
Jul 2014
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K141728 is an FDA 510(k) clearance for the ACE CALIBRATOR, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on July 28, 2014, 32 days after receiving the submission on June 26, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K141728 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2014
Decision Date July 28, 2014
Days to Decision 32 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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